Renal Cell Carcinoma Clinical Trial
Official title:
Neoadjuvant AXITINIB and AVELUMAB for Patients With Localized Clear-cell RCC and a Moderate to High Risk
a monocenter, open label, single arm, phase II study of the combination of axitinib with avelumab as neoadjuvant therapy in patients with intermediate to high-risk non-metastatic RCC.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | January 31, 2025 |
Est. primary completion date | January 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Signed and written informed consent - Male or female patients age = 18 years - Histologically confirmed diagnosis of non-metastatic clear-cell renal cell carcinoma of intermediate to high risk with completely resectable primary tumours. - World Health Organization performance status of 0-1. - Adequate coagulation function as defined in protocol - Adequate hematological function as defined in protocol - Adequate hepatic function as defined in protocol - Adequate renal function as defined in protocol - Negative serum pregnancy test at screening for women of childbearing potential. - Highly effective contraception for both male and female subjects if the risk of conception exists. Exclusion Criteria: Renal tumors of low risk or M1 - Non-clear cell histology at biopsy - Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product - Corrected QT interval (QTc) > 480 msecs - History of any of the cardiovascular conditions defined in the protocol within the past 6 months - Poorly controlled hypertension - History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. - Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer - Evidence of active bleeding or bleeding diathesis. - Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures. - Unable or unwilling to discontinue use of prohibited medications to be listed in protocol for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study - Treatment with any of the following anti-cancer therapies: chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of axitinib or avelumab - Administration of any non-oncologic investigational drug within 30 days or 5 half lives whichever is longer prior to receiving the first dose of study treatment - Prior organ transplantation, including allogeneic stem cell transplantation - Significant acute or chronic infections as defined in protocol - Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent - Known severe hypersensitivity reactions to monoclonal antibodies - Pregnancy or lactation - Known alcohol or drug abuse |
Country | Name | City | State |
---|---|---|---|
Netherlands | Antoni van Leeuwenhoek | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
The Netherlands Cancer Institute | Pfizer |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | number of patients with partial remission | according to RECIST 1.1. | week 12 of neoadjuvant treatment | |
Secondary | toxicity | measured by number and grade of adverse events | up to 90 days after end of treatment | |
Secondary | event free survival and overall survival | Time from registration to disease progression or death | assessed up to 10 years |
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